Reflexology and meditative practices for symptom management among people with cancer: Results from a sequential multiple assignment randomized trial.

Optimal sequencing of complementary therapies can help improve symptom management through nonpharmacological approaches. A 12-week sequential multiple assignment randomized trial comparing home-based reflexology and meditative practices on severity of fatigue and other symptoms was conducted among patients with cancer and their informal caregivers. Dyads were initially randomized to reflexology (N = 150), meditative practices (N = 150), or control (N = 47). If patient's fatigue did not improve (nonresponse) after 4 weeks of reflexology or meditative practices, the dyad was rerandomized to either add the other therapy or continue with the original therapy for weeks 5-8. Four decision rules (DRs) were compared: (1) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, continue with reflexology for another 4 weeks, thus providing a higher dose; (2) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, add meditative practices for the next 4 weeks; (3) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, continue meditative practices for another 4 weeks, thus providing a higher dose; and (4) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, add reflexology for the next 4 weeks. Symptoms were evaluated weekly using the M.D. Anderson Symptom Inventory (MDASI). Clinically, nurses can recommend either therapy since no differences were found among the 4 DRs, with the exception of lower severity for summed MDASI symptoms at week 8 for the use of reflexology only (DR-1) versus DR-2 (sequencing reflexology to meditative practices). Adding the other therapy for nonresponders after 4 weeks may not be warranted.

Ranibizumab Alters Levels of Intraocular Soluble Cytokine Receptors in Patients with Diabetic Macular Edema.

Purpose: Ranibizumab, an anti-VEGF-A (vascular endothelial cell growth factor-A) monoclonal antibody fragment, is a well-established treatment for diabetic patients with macular edema. However, very little is known about the effect of ranibizumab on intraocular regulation of pro - and anti-inflammatory signaling pathways and their regulation of VEGF family members, which was the aim of this study.Materials and Methods: Diabetic patients (n = 10) aged ≥18 years with central diabetic macular edema, BCVA >24 and <78, and central macular thickness (CMT) greater than 250 µm were enrolled in this study. Following a full eye exam, imaging, and an aqueous tap, patients received ranibizumab (0.3 mg/0.05 mL) injections at day one and weeks four and eight. At week 12, a full eye exam, imaging, and a second aqueous tap was obtained prior to the last injection of ranibizumab. Pre - and post-treatment aqueous humor samples were then analyzed using Milliplex MAP magnetic bead assays.Results: As expected, ranibizumab lowered levels of VEGF-A, decreased CMT, and improved VA (visual acuity). In addition, it significantly lowered aqueous levels of IL-10, IFNγ, sIL-1R1, sIL-1R2, sRAGE, and VEGF-D. Changes in levels of VEGF-A and VEGF-C strongly correlated with changes in soluble receptors, sgp130 and sIL-6R, associated with IL-6 signaling pathways. In contrast, changes in VEGF-D correlated with sIL-1R1 and sIL-1R2, soluble receptors participating in IL-1 signaling. Changes in CMT and VA did not correlate with changes in levels of VEGF family members. However, post-treatment values of CMT correlated with post-treatment levels of VEGF-C. Post-treatment VA values correlated with a wide variety of potential biomarkers linked to inflammation.Conclusions: Ranibizumab treatment had strong effects on regulating levels of soluble receptors closely linked to IL-1 and IL-6 signaling pathways. Therefore, a complete understanding of the actions of ranibizumab will further the development of additional therapies to support treatment of diabetic macular edema.